Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures

Not yet recruiting

• Conditions: Cholangiocarcinoma; Biliary Stricture

• Registration Number: NCT06369896
• Lead Sponsor: Soonchunhyang University Hospital

Brief Summary

This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.

Detailed Description

Although early and accurate diagnosis of cholangiocarcinoma from the biliary stricture is important, accurate differential diagnosis is still difficult even in computed tomography and magnetic resonance imaging. We planned to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of biliary stricture.

Study Timeline

• Study First Submitted: 2024-01-21
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17
• Study Start: 2024-05-05
• Primary Completion: 2025-12-25
• Study Completion: 2026-12-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patients aged 19 to under 80
2. Presence of nonicteric biliary stricture
3. Previous endoscopic sphincterotomy or papillary balloon dilatation

Exclusion Criteria

1. Bleeding tendency (INR > 1.5 or platelets < 50000 mm3)
2. Contraindication to ERCP

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of SOC	From enrollment through study completion, an average of 1 year	sensitivity, specificity, and accuracy of SOC

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy of IDUS	From enrollment through study completion, an average of 1 year	sensitivity, specificity, and accuracy of IDUS
Technical success of IDUS	From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed	Successful observation of extrahepatic duct using IDUS
Technical success of SOC	From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed	Successful observation of extrahepatic duct using SOC
Adverse event	From enrollment through study completion, an average of 1 year	All adverse event according to the American Society of Gastrointestinal Endoscopy criteria